FDA Adverse Event
Death
Summary report: N
OVATIO
MDR report key: 2943986
·
Received February 1, 2013
Report
- Report Number
- 9610579-2013-00006
- Event Type
- Death
- Date Received
- February 1, 2013
- Date of Event
- January 16, 2013
- Report Date
- January 22, 2013
- Manufacturer
- SORIN CRM
- Product Code
- MRM
- PMA / PMN Number
- P9800049
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DATE: (B)(6) /2013. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.
Description of Event or Problem · 1
THE PATIENT PASSED AWAY FOR AN UNKNOWN REASON. ON THE PATIENT FILE DATED (B)(6) 2013, THE HEART RATE CURVE AND THE AUTOSENSING HISTOGRAMS WERE NOT AVAILABLE. AN EXPLANATION WAS REQUIRED. IN ADDITION, SOME CLARIFICATIONS CONCERNING THE RECORDED EPISODES (RHYTHM, THERAPY DELIVERED...) ON (B)(6) 2013, WERE REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 44751 | OVATIO | MRM | SORIN CRM | OVATION DR 6550 | S080305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |